Lenvatinib Plus Pembrolizumab Improves Overall Survival Compared to Sunitinib as First-Line Treatment for Advanced RCC in the CLEAR Trial

By Hiten D. Patel, MD, MPH - March 26, 2021

The phase 3 CLEAR trial demonstrated an improvement in overall survival (OS) for lenvatinib plus pembrolizumab over sunitinib as first-line therapy for advanced renal cell carcinoma (RCC). In a presentation during the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium, Dr. Robert J. Motzer and colleagues reported on results comparing two combination therapies involving lenvatinib to sunitinib.

A total of 1,069 patients were randomized in the trial with median progression-free survival (PFS) estimates of 23.9 months for lenvatinib plus pembrolizumab, 14.7 months for lenvatinib plus everolimus, and 9.2 months for sunitinib. While PFS was superior for both combination groups compared to sunitinib, an OS benefit was only seen for lenvatinib plus pembrolizumab (hazard ratio, 0.66; 95% confidence interval, 0.49-0.88; P=0.005) compared to sunitinib. Treatment-related grade ≥3 adverse events were observed for 72% of patients receiving lenvatinib plus pembrolizumab compared to 59% for sunitinib.

It is unknown how lenvatinib plus pembrolizumab compares to other recently emerged combination therapies involving checkpoint inhibitors in the first-line setting for advanced RCC. However, the complete response rate of 16.1% is very noteworthy and makes lenvatinib plus pembrolizumab a promising addition to the armamentarium of medical oncologists.


J Clin Oncol 39, 2021 (suppl 6; abstr 269)

Motzer R, Alekseev B, Rha SY, et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021 Feb 13 (Epub ahead of print. PMID: 33616314.)

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